The HIV clinical trial landscape in 2026
HIV medicine is undergoing its most consequential transformation since the introduction of combination antiretroviral therapy in the mid-1990s. For four decades, daily oral pills were the universal standard of HIV treatment and prevention. That is now changing. The approval of long-acting cabotegravir/rilpivirine (Cabenuva, ViiV Healthcare/Janssen) for treatment in 2021 and the dramatic results of the PURPOSE 1 and PURPOSE 2 trials with lenacapavir (Sunlenca, Gilead) — showing near-complete prevention of HIV acquisition with a twice-yearly injection — have validated a new paradigm: injectable therapy that removes the daily adherence burden entirely. The FDA approved lenacapavir-based PrEP in 2024, a landmark that has reorganized the competitive landscape and is driving a new generation of clinical trial registrations.
Simultaneously, the scientific community has never been closer to a functional HIV cure. The "shock-and-kill" hypothesis — reactivating the latent viral reservoir and then clearing it — has been refined through years of trials; "block-and-lock" strategies that permanently silence the reservoir are entering clinical evaluation. Broadly neutralizing antibodies (bnAbs) can suppress viremia in the absence of antiretroviral therapy in some patients and are being evaluated both as treatment and as components of cure strategies. CAR-T cell therapies re-engineered to target HIV-infected cells are in early Phase 1 trials. The pipeline has never been more mechanistically diverse.
The recruiting trials in our database reflect the full breadth of this pipeline: from ViiV Healthcare and Gilead's head-to-head long-acting formulation programs to NIH/NIAID-funded cure research at Johns Hopkins, Yale, and the HIV Vaccine Trials Network. TB-HIV co-infection — particularly relevant for global health programs — is a distinct and active research domain. DataLookout tracks across all of these areas so no new registration goes unnoticed.
- Long-acting ART for treatment — cabotegravir/rilpivirine IM (Cabenuva, approved), lenacapavir SC (approved), islatravir combinations, VH4 (ViiV next-gen pipeline)
- Long-acting PrEP — injectable cabotegravir (Apretude, approved), lenacapavir (approved for PrEP 2024), broadly neutralizing antibodies as PrEP
- Broadly neutralizing antibodies (bnAbs) — VRC01, PGT121, N6LS, 3BNC117, 10-1074 (in combinations and as monotherapy for reservoir clearance)
- HIV cure strategies — shock-and-kill (TLR agonists, HDAC inhibitors as LRAs), block-and-lock (didehydro-cortistatin A analogs), therapeutic vaccines
- CAR-T cell therapy for HIV — CD4-based constructs, dual-targeting approaches
- TB-HIV co-infection — rifampicin-compatible regimens, shorter TB treatment in PLHIV, ACTG network trials
- HIV in special populations — pediatric long-acting formulations, HIV in aging/comorbidities, HIV-associated neurocognitive disorders
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Our system pulls from the ClinicalTrials.gov API every day. For an HIV watch profile, you can configure a saved search for:
- Keywords: "HIV," "HIV-1," "HIV infection," "antiretroviral," "ART," "PrEP," "pre-exposure prophylaxis," "long-acting," "broadly neutralizing antibody," "bnAb," "HIV cure," "latent reservoir," "lenacapavir," "cabotegravir," "islatravir," "CAR-T HIV"
- Phase filters: Phase 1 (novel mechanisms, cure strategies, first-in-human bnAbs), Phase 2 (proof-of-concept, combination bnAb studies), Phase 3 (pivotal long-acting ART/PrEP trials)
- Sponsor type: large pharma (ViiV Healthcare, Gilead, Janssen), academic/NIH networks (ACTG, HPTN, HVTN), global health funders (Gates Foundation-sponsored)
- Study status: not yet recruiting, recruiting, active not recruiting
- Sub-population: treatment-naive, virologically suppressed, pediatric/adolescent, pregnant women, TB co-infected, long-term non-progressors
The long-acting revolution in HIV — what the PURPOSE trials mean for the pipeline
The PURPOSE 1 and PURPOSE 2 trials for lenacapavir-based PrEP represent one of the most significant clinical results in HIV prevention since the original iPrEx trial established oral PrEP in 2010. PURPOSE 1, conducted in cisgender women in sub-Saharan Africa, showed zero infections in the lenacapavir arm — 100% efficacy — against a background incidence rate of approximately 2.4 per 100 person-years. PURPOSE 2, conducted in a diverse global population including men who have sex with men and transgender women, showed 96% efficacy compared to oral tenofovir/emtricitabine. Gilead received FDA approval for lenacapavir PrEP in 2024, making it the first injectable agent approved for HIV prevention.
The commercial and pipeline implications are substantial. ViiV Healthcare, whose injectable cabotegravir (Apretude) had been the leading long-acting PrEP option, faces direct competition. Both companies are now running trials exploring next-generation formulations — longer dosing intervals (annual or beyond), oral lead-in alternatives, and adolescent/pediatric data packages. The race toward annual or even longer-acting formulations will generate a steady cadence of new Phase 2 and Phase 3 registrations over the next three to five years.
For HIV cure research, the long-acting paradigm has also created a new opportunity: bnAb-based "analytical treatment interruption" trials — where long-acting antibodies are used to maintain viral suppression in the absence of ART — are now feasible as outpatient protocols in a way that daily-oral-dependent designs could not support. BD teams, investors, and global health researchers tracking the HIV space need daily visibility into this rapidly shifting pipeline to make informed decisions about partnering, licensing, and advocacy.
Who uses HIV trial monitoring
- Infectious disease pharma BD teams — tracking long-acting ART, PrEP, bnAb, and cure-strategy registrations from ViiV, Gilead, and emerging biotechs; monitoring Phase 3 transitions and new formulation programs
- Global health researchers and funders — monitoring ACTG, HPTN, and Gates-funded trials for TB-HIV, pediatric, and resource-limited settings programs
- HIV advocacy organizations — tracking access to long-acting therapies, inclusion of key populations (cisgender women, transgender individuals, PWID) in pivotal trials, and compassionate use programs
- CROs with infectious disease practices — identifying new sponsor relationships and site qualification opportunities for complex long-acting and cure-strategy protocols
- Academic infectious disease programs and KOLs — monitoring industry cure and bnAb programs for investigator-site participation, collaborative research, and publication opportunities
Know what changed, not just that something did
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Start Free — No Credit Card1082 active trials, 516 recruiting.
Industry sponsors run 88 of these trials. The rest are run by universities, hospitals, government bodies and other non-commercial sponsors. The table below lists the 5 largest of 25.
| Top industry sponsor | Active trials |
|---|---|
| Gilead Sciences | 26 |
| ViiV Healthcare | 25 |
| Merck (MSD) | 11 |
| BioNTech SE | 2 |
| Jecho Biopharmaceuticals Co., Ltd. | 2 |
| Trial | Status | Latest tracked change | Seen |
|---|---|---|---|
| C-3002: Enhancing Cervical Cancer Screening Access and Follow-up Care at… NCT07520188 | Not Yet Recruiting | Completion pushed: 2027-05 → 2028-03-31 | 2026-09-02 |
| Enhancing PrEP Uptake and Retention Among Latine TGW and GBM in the South Using… NCT07218211 | Recruiting | Completion moved earlier: 2028-01-05 → 2027-07-31 | 2026-08-27 |
| Expanding the Potential of Couples HIV Testing: Adjunct Modules to Reduce Drug… NCT05000866 | Active, Not Recruiting | Completion pushed: 2026-05-31 → 2027-01-31 | 2026-09-16 |
| South Africa Smoking Cessation and Engagement in HIV/TB Care Care NCT05842161 | Recruiting | Completion pushed: 2026-05-31 → 2027-05-31 | 2026-09-10 |
| RV630 - Approach to Control HIV With Immune Enhancement and Vaccination (ACHIEV NCT06484335 | Recruiting | Completion pushed: 2027-08-01 → 2029-07-17 | 2026-09-05 |
Each trial page shows every change DataLookout has recorded for that trial.
DataLookout checks ClinicalTrials.gov every day and records what changed on each trial: status, enrollment, phase, primary endpoint, completion dates, sites, sponsor, and the stated reason a trial stopped. Add a sponsor or a disease to your watchlist, or save any search, and the changes arrive in a daily or weekly email digest.
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Starter, $49/month: 3 sponsor + 3 disease watchlists, 3 saved searches in your email digest, track up to 25 individual trials, full Trials at Risk list and landscape reports.
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